Position

Manager – Production (Fluorescence Immunoassay - FIA, Uncut Sheet Production)

Department

Production

Reporting To

Head – Manufacturing / Plant Head

Location

SD Biosensor Healthcare Pvt. Ltd.

IMT Manesar, Gurugram, Haryana

Job Summary The Manager – Production (FIA) will be responsible for leading the Fluorescence Immunoassay (FIA) Uncut Sheet manufacturing operations, ensuring production targets are achieved while maintaining the highest standards of quality, regulatory compliance, safety, and cost efficiency. The role involves managing production teams, driving continuous process improvements, coordinating with cross-functional departments, and ensuring adherence to ISO 13485, GMP, and Medical Device manufacturing requirements.

Key Responsibilities

Production Management

- Plan, organize, and supervise daily FIA Uncut Sheet manufacturing activities.
- Ensure achievement of production targets while maintaining quality standards.
- Optimize manpower utilization and production scheduling.
- Monitor production performance and improve productivity.

Team Leadership

- Lead, mentor, and develop production supervisors and operators.
- Build a high-performance production team.
- Conduct skill development and technical training programs.
- Drive employee engagement, discipline, and workplace safety.

Quality & Compliance

- Ensure compliance with ISO 13485:2016, GMP, and applicable Medical Device regulations.
- Maintain complete production documentation and batch records.
- Support internal, customer, and regulatory audits.
- Implement and monitor CAPA activities.

Validation & Documentation

- Support equipment and process validation activities including:
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- PV (Process Validation)
- DQ (Design Qualification)
- URS preparation and review
- Review SOPs, BMRs, work instructions, and validation protocols.

Process Improvement





- Identify production bottlenecks and implement corrective actions.
- Reduce production waste and improve operational efficiency.
- Analyze production data and implement Lean Manufacturing initiatives.
- Improve OEE, yield, and production cycle time.

Equipment Management

- Ensure proper operation and maintenance of production equipment.
- Coordinate preventive and breakdown maintenance with Engineering.
- Minimize equipment downtime.

Cross Functional Coordination

- Work closely with:
- Quality Assurance
- Quality Control
- R&D;
- Warehouse
- Engineering
- Planning
- Supply Chain
- Support new product introduction and technology transfer.

Inventory & Material Management

- Plan raw material requirements.
- Coordinate procurement planning.
- Monitor material consumption and reduce wastage.

Reporting & MIS

- Prepare daily, weekly, and monthly production reports.
- Present production KPIs to senior management.
- Monitor productivity, rejection, downtime, and efficiency.

Safety & Regulatory Compliance

- Ensure compliance with EHS guidelines.
- Promote safe working practices.
- Ensure implementation of 5S and Positive Manufacturing Practices.

Key Performance Indicators (KPIs)

- Production Target Achievement (%)
- Overall Equipment Effectiveness (OEE)
- Batch Yield (%)
- Right First Time (RFT)
- Rejection Rate
- Productivity per Employee
- Machine Downtime
- CAPA Closure
- Audit Compliance Score
- Documentation Accuracy
- Material Wastage (%)
- On-Time Production Completion
- Training Compliance
- Safety Incidents (Zero LTI Target)

Education

- Bachelor's Degree in Biotechnology, Microbiology, Biochemistry,



Biomedical Engineering, Mechanical Engineering, Industrial Engineering, Pharmacy, or a related discipline.
- Master's Degree preferred (MBA Operations / M.Sc. / M.Tech. is an added advantage).

Experience

- 8–15 years of experience in Medical Device, IVD, Diagnostics, Biotechnology, or Healthcare Manufacturing.
- Minimum 5 years in a leadership role managing FIA production or similar immunoassay manufacturing operations.
- Hands-on experience in FIA Uncut Sheet manufacturing is highly preferred.

Technical Skills

- FIA Manufacturing Process
- ISO 13485:2016
- GMP
- Medical Device Manufacturing
- IQ, OQ, PQ, DQ, PV
- CAPA
- Root Cause Analysis
- Lean Manufacturing
- 5S
- Process Validation
- Production Planning
- ERP/SAP
- MS Excel (Advanced)
- Production MIS Reporting

Behavioral Competencies

- Leadership
- Decision Making
- Problem Solving
- Analytical Thinking
- Team Management
- Communication Skills
- Planning & Organizing
- Time Management
- Continuous Improvement Mindset
- Accountability
- Cross-functional Collaboration

Preferred Industry

- Medical Devices
- In-Vitro Diagnostics (IVD)
- Fluorescence Immunoassay (FIA)
- Lateral Flow Assay Manufacturing
- Diagnostics Manufacturing
- Biotechnology
- Pharmaceutical Manufacturing

Salary As per company standards and candidate experience.

Employment Type

Full time | Permanent

Why Join SD Biosensor Healthcare Pvt. Ltd.?

- Work with a global leader in In-Vitro Diagnostics (IVD).
- Opportunity to lead advanced FIA manufacturing operations.
- Exposure to international quality and regulatory standards.
- Career growth in a rapidly expanding medical device organization.
- Collaborative and innovation-driven work environment.

Pay: ₹50,000.00 - ₹120,000.00 per month

Benefits

- Cell phone reimbursement
- Food provided
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund

Work Location: In person

📌 Manager Production (Gurugram)
🏢 SD Biosensor Healthcare
📍 Gurugram